Manufacturing Associate , Drug Product Filling; 2nd Shift

Manufacturing Associate 4, Drug Product Filling (2nd Shift - 3PM-11:30PM)

Company:
FUJIFILM Biotechnologies

Location:

North Carolina, United States

Salary: $25.37 - $42.29 per hour

The manufacturing associate in Drug Product Manufacturing will have a primary task of operating the filling line and all related tasks. This role supports projects that influence manufacturing processes, including training of others, and assists in scheduling daily manufacturing activities for the team. The facility operates 24/7, so the role may require flexibility with working hours or shift rotation.

During the project phase:

• Participate and support testing activities, such as FAT, PQ, etc.
• Support and contribute to the preparation of documentation packages (e.g., SOPs, work instructions).
• Contribute to the preparation for operational readiness related to bulk drug product manufacturing.
• Possible assignments include project support for procedure review/creation, development or transfer of manufacturing business processes, and testing and commissioning support.
• Travel up to 0-25% (international or domestic) may be required during the project phase.

In operations:

• Lead, execute and document manufacturing processing steps and/or support activities, including process monitoring and control.
• Perform operations of the drug product filling line.
• Execute validation protocols according to cGMP SOPs.
• Establish processes and trainings to become a trainer for coworkers.
• Maintain compliance of GMP documents and ensure training level is compliant and maintained.
• Support or assist senior associates or supervisors with scheduling daily activities on the drug product manufacturing floor.
• Perform other duties as assigned.
• Shift work (weekend and potential nights) is required.

• High School Diploma or GED.
• 6+ years of direct experience in a manufacturing environment.

• Associate’s Degree + 4 years of direct experience in a cGMP manufacturing environment, or BA/BS + 2 years of direct experience in a cGMP manufacturing environment.
• Equivalent military training or experience.
• Experience on specific unit operations (e.g., viral filtration and bulk dispensing).
• Understanding of manufacturing run cadence and order of shift activities.
• Knowledge of cGMP, safety, and operational procedures.
• High degree of knowledge and expertise of the operation of specific production equipment.

• Exposure to environments requiring respiratory protection.
• Exposure to noisy environments.
• Normal range of vision.
• Climb ladders and stairs of various heights.
• Experience prolonged sitting, standing, walking, bending, stooping, and stretching throughout the shift, up to 12 hours.
• Use hand-eye coordination and manual dexterity sufficient to operate a computer keyboard, telephone, calculator, and other office equipment.
• May be required to lift up to 50 pounds on occasion.